Recently in Generic Drug Problems Category

ConsumerLab.com Finds Generic Antidepressant Behaves Differently from Original Drug.  May Explain Complaints by Patients.

WHITE PLAINS, NEW YORK AND DURHAM, NORTH CAROLINA  — ConsumerLab.com reported today that its tests of a generic version of the popular antidepressant drug Wellbutrin showed differences between the generic and original that might explain recent consumer complaints about the generic product.  In February, readers of The People’s Pharmacy® syndicated newspaper column began reporting problems with a generic version of once-a-day Wellbutrin XL 300.  Prior to generic competition, annual U.S. sales of Wellbutrin XL 300 mg were nearly one billion dollars.

The ConsumerLab.com report, available at www.consumerlab.com/results/wellbutrin-bupropion.asp, shows that the generic product released drug at a very different rate than the original Wellbutrin XL.  Tests also showed that two generic bupropion SR (twice-a-day) products released drug somewhat differently – although these were within the fairly wide limits permitted by the FDA.  Time-released generic drugs often use tablet technologies different from the original product, possibly explaining the variations found.

Personal accounts posted at www.peoplespharmacy.com generally indicate that while taking the brand name antidepressant Wellbutrin XL 300 for months or years, people felt well and their psychological symptoms of depression were successfully controlled. After switching to a generic formulation many reported symptoms such as headaches, irritability, nausea and insomnia – known side-effects of bupropion. Others shared stories of becoming easily upset or aggressive, crying, gaining weight or experiencing a return of depressive symptoms. Some reported thoughts of suicide while taking the generic form of Wellbutrin. A large number of accounts note that returning to the original product brought symptoms under control.

Joe and Teresa Graedon, co-authors of The People’s Pharmacy®, immediately reported these cases to officials at the Food and Drug Administration who assured the Graedons that the FDA would look into the issue. The agency has not yet reported the results of its investigation.  The Graedons, aware of ConsumerLab.com’s experience in testing health and nutrition products, suggested that it initiate laboratory testing to see whether there was any measurable difference between the generic formulation and the originator product.

Tod Cooperman, MD, President of ConsumerLab.com, stated that “This information shatters the myth that generics are always identical to the original and it questions the belief that generics are always equivalent. Even if the active ingredient is the same, releasing it at a different rate may alter a drug’s effects.”  He added, “Generic drugs are essential to keeping medical costs down, but consumers and healthcare providers need to be aware of the potential differences among products otherwise thought to be the same.  Generics are not clinically tested for safety and efficacy, so the consumer will be the first to find out if there is a problem.”  ConsumerLab.com intends to publish additional reports on generic drugs on its website.

The testing was funded by ConsumerLab.com without drug company involvement. The full report is available to ConsumerLab.com subscribers at www.consumerlab.com/results/wellbutrin-bupropion.asp.  The report includes test results, information about other generic versions of bupropion on the market, and a list of other popular extended-release generic drugs.  The Graedons and The People’s Pharmacy® receive no financial support from pharmaceutical companies. Reports of generic drug problems by consumers are posted at www.peoplespharmacy.com.

ConsumerLab.com is a leading provider of consumer information and independent evaluations of products that affect health and nutrition. Reviews of popular types of vitamins and supplements are also available at www.consumerlab.com.  Soon to be released are new Product Reviews of magnesium, resveratrol (red wine extract), potassium, and omega-3 and -6 fatty acids and turmeric. Subscription to ConsumerLab.com is available online.  The company is privately held and based in Westchester, New York. It has no ownership from, or interest in, companies that manufacture, distribute, or sell consumer products.

The People’s Pharmacy® is a leading provider of consumer health information. Joe Graedon, MS, pharmacology, and Teresa Graedon, PhD, medical anthropology, have been writing a syndicated newspaper column (distributed by King Features Syndicate) for 29 years. They co-host The People’s Pharmacy® radio show heard on more than 125 public radio stations. They have written more than 10 consumer-related health books that address pharmaceuticals, herbs and dietary supplements.
For further information, contact Tod Cooperman, MD, at: tod.cooperman@consumerlab.com
Joe or Teresa Graedon can be reached at: peoplespharmacy@gmail.com

In the field of pharmaceuticals, Americans have been told that price doesn't matter. Generic drugs are supposed to be identical to their brand name counterparts. For nearly 30 years, we believed this argument. We encouraged people to save money by insisting that their physicians prescribe generics whenever they were available.

All that changed several years ago when some pharmacists started telling us they had doubts about the quality of certain generic products. We also began getting letters from readers who had trouble with their generic prescriptions. Readers have shared their disappointment with generic pain relievers, antidepressants, blood pressure medicines and diabetes drugs. The generic drug manufacturers discount these reports.

Kathleen Jaeger, president and ceo of the Generic Pharmaceutical Association, has written: "To set the record straight, there are no differences between FDA-approved brand and generic medicines. A generic must meet the same high standards as the brand-name drug, with the same safety and effectiveness, same active ingredients, same strength and dosage, same labeling and use and same high quality manufacturing standards."

While we agree with Ms. Jaeger that FDA approval is rigorous, we worry that once drugs are approved and marketed, monitoring is spotty at best. For the most part, the pharmaceutical industry runs on the honor system. The FDA is not capable of analyzing more than a handful of pill bottles from pharmacy shelves each year. As a result, unscrupulous manufacturers or counterfeiters may be slipping substandard generics into the marketplace.

Joe and Terry Graedon